Rituximab denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for medications, Gamunex 70 grams intravenous (IV) and rituximab 800 mg IV for treatment of the enrollee who has a history of failed kidney transplants. Findings: The physician reviewer found that The patient is with a fourth kidney transplant. His end stage renal disease (ESRD) is attributed to chronic glomerulonephritis. His first three transplants were lost to immunologic problems, presumably acute and chronic rejection. He is highly sensitized against human leukocyte antigens (HLA). The currently functioning transplant was the result of a paired exchange program. He received an ABO incompatible and HLA incompatible organ. Desensitization was performed with plasmapheresis and intravenous immunoglobulins (IVIG) plus rituximab.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient with a diagnosis of primary membranous nephropathy has requested authorization and coverage for rituximab 10 mg infusion with a quantity of 100 units. The records document that this patient presents with a history of stage 4 chronic kidney disease. The patient’s provider has recommended continued treatment with rituximab. As noted in the current medical literature, rituximab is considered the standard of care therapy for patients with membranous nephropathy. Chronic kidney disease is a chronic condition and in the absence of appropriate treatment, this patient is at high risk of progression. The provider reported that this patient is receiving treatment with rituximab, which is a well-supported therapy for membranous nephropathy and consistent with current medical literature recommendations.

Where the denial was upheld

SummaryThe patient is a 30-year-old female with a diagnosis of relapsing-remitting multiple sclerosis (MS). She request authorization of IV rituximab. The request was denied by the Health Plan based upon a determination that the therapy is not medically necessary. The reviewing physician concluded that the Health Plan denial should be upheld. Analysis and FindingsClinical Facts: The patient has relapsing-remitting multiple sclerosis (MS). She has had a substantial progression of disability since she was diagnosed in 1999, despite treatment with Copaxone and Rebif. The patient has also been treated with courses of steroids for acute flares, but has not regained her baseline status. An evaluation in the MS clinic resulted in a recommendation for more aggressive therapy with Novantrone.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for rituximab for treatment of the enrollee’s systemic sclerosis.Findings: The physician reviewers found that this is a case of systemic sclerosis manifested by skin findings, gastroesophageal reflux disease (GERD) with esophagitis, Raynaud’s and myopathy. Previous therapy has included methotrexate which was stopped for three weeks due to axillary lymph node, and mycophenolate. However, the patient’s records do not document treatment or a contraindication to treatment with cyclophosphamide. The current literature demonstrates a possible benefit of rituximab in skin symptoms, but larger, randomized controlled studies have not been performed to confirm the safety and effectiveness of this treatment.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Rituximab, then check the rights and deadlines that apply to your plan.